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目的:建立RP-HPLC法测定盐酸小檗碱及其相关物质含量。方法:选用Luna C_(18)柱,5μm,4.6mm×300mm,乙腈-缓冲液(0.05mol·L~(-1)磷酸二氢钾和0.05mol·L~(-1)庚烷磺酸钠,1:1)(40:60)为流动相,检测波长263nm,流速:1.0mL·min~(-1),柱温:30℃,进样量:20μL。结果:在4.27～85.40μg·mL~(-1)浓度范围内,线性关系良好,回归方程Y=7.373×10~7X+3.722×10~4,r=0.999 9。平均回收率为100.4％(n=9)。结论:本法简便、灵敏、准确。
Objective: To establish a RP-HPLC method for the determination of berberine hydrochloride and its related substances. Methods: Luna C_ (18) column, 5μm, 4.6mm × 300mm, acetonitrile-buffer solution (0.05mol·L -1 potassium dihydrogen phosphate and 0.05mol·L -1 heptanesulfonate) , 1: 1) (40:60) as the mobile phase. The detection wavelength was 263nm, the flow rate was 1.0mL · min -1, the column temperature was 30 ℃, and the injection volume was 20μL. Results: In the range of 4.27 ~ 85.40μg · mL ~ (-1), the linear relationship was good. The regression equation was Y = 7.373 × 10 ~ 7X + 3.722 × 10 ~ 4, r = 0.999 9. The average recovery was 100.4% (n = 9). Conclusion: This method is simple, sensitive and accurate.